EDMONTON, Dec. 11 /CNW/ - CardioMetabolics(TM) inc. announced today that
it has enrolled the 40th patient, the enrolment midpoint, in its Phase II
clinical trial. "Mini-METR(*)ICS" is evaluating CardioMetabolics' proprietary
intravenous formulation of dicholoracetate (DCA i.v.) in high risk geriatric
patients undergoing open heart surgical procedures. This trial is meant to
support the design of the Phase III "METR(*)ICS" (METabolic Treatment In Cardiac
Surgery) trial by identifying the relevant clinical parameters, such as the
reduction in time a patient spends in the intensive care unit following an
open heart surgery procedure.
"The clinical team at the University of Alberta Hospital is conducting
this trial on schedule and within budget. Based on our timelines, we expect to
complete the Phase II trial in the third quarter of 2008 and be able to review
the results at that time in preparation for the Phase III METR(*)ICS trial,"
said Kimmo Lucas, President and CEO.
CardioMetabolics has already received a Special Protocol Assessment (SPA)
from the U.S. Food and Drug Administration for a Phase III trial of DCA i.v.
Therefore, while the Phase II trial is not a regulatory requirement, it will
provide key information for finalizing the design of the Phase III protocol.
The Phase II trial is a double-blind, placebo-controlled trial evaluating
80 high risk geriatric patients following open heart surgery procedures.
Patients receive either DCA i.v. or a placebo, initially administered as a
bolus infusion immediately after surgery and then as a continuous infusion for
24 hours. The primary endpoint of the trial is to demonstrate a trend in
reducing the recovery time spent in the intensive care unit following surgery
by the treatment group compared to placebo.
Edmonton-based CardioMetabolics(TM) inc. is a privately held, late-stage
biopharmaceutical company focused on commercializing drug product candidates
in the novel class of energy metabolism agents, referred to as PDK blockers.
The Company has late stage and earlier stage compounds that target the
treatment of cardiovascular disease, and related metabolic conditions (e.g.,
diabetes). Cardiovascular disease is the "number one" cause of death in North
America, and each year in the United States alone, over 700,000 open heart
surgeries are conducted. CardioMetabolics' technology is focused on metabolic
modulation, through the use of dichloroacetate (DCA) and related compounds,
which improve energy production by favoring glucose metabolism.
CardioMetabolics(TM) inc. was recently recognized as "Emerging Company of the
Year" at BioAlberta's 8th Annual AGM and Awards Gala held November 28, 2007 in
Except for historical information, this press release may contain
forward-looking statements, which reflect the Company's current expectation
regarding future events. These forward-looking statements involve risk and
uncertainties, which may cause but are not limited to, changing market
conditions, the successful and timely completion of clinical studies, the
establishment of corporate alliances, the impact of competitive products and
pricing, new product development, uncertainties related to the regulatory
approval process and other risks detailed from time to time in the Company's
ongoing quarterly and annual reporting.
For further information:
For further information: CardioMetabolics inc.: Kimmo Lucas, President
and Chief Executive Officer, Phone: (780) 438-2813, Fax: (780) 438-2874,
E-mail: email@example.com, Internet: http://primalfx.com/cardio;
Investor Relations: Ross Marshall, The Equicom Group Inc., Phone: (416)
815-0700 (Ext. 238), Fax: (416) 815-0080, E-mail: firstname.lastname@example.org